Grain Fibre and Gut Health

NCT03550365 | Completed

• 1 other identifier: 84/2010
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Wholegrain fibre is known to affect on the gut health, but also may cause intestinal discomfort. Thus, many individuals may avoid the consumption of whole grain cereals in spite of their known health benefits, and may in this regard consume more restricted diets. In the preset study the aim was to technologically modify the cereal fibres to improve its usability and to maintain its health beneficial properties. The objective was to investigate intestinal fermentation of grain dietary fibre and associated effects on gut-mediated metabolic health, such as immunological health and adipose tissue function. The hypothesis was that whole grain products maintain their original beneficial health effects and may be better tolerable when the bran is technologically modified. Additionally, it was hypothesized that gut-mediated bioavailability of plant cell wall compounds and their metabolites affect the metabolic health through their immunomodulatory effects.

Conditions

Intestinal Disorder; Glucose Metabolism Disorders; Inflammation

Outcome Measures

Primary Outcomes (1)

• gastrointestinal symptoms

  intestinal discomfort measured by questionnaire

  4 week dietary period

Secondary Outcomes (8)

• Glucose concentration

  4 week dietary period

• Insulin concentration

  4 week dietary period

• fecal microbiota

  4 week dietary period

• Exhaled air

  4 week dietary period

• highly sensitive C-reactive protein

  4 week dietary period

Study Arms (3)

Rye bran bread intervention

EXPERIMENTAL

4 week rye bran bread diet intervention with dietary fibre intake of 30g

Other: Rye bran bread intervention

Rye bread intervention

EXPERIMENTAL

4 week rye bread diet intervention with dietary fibre intake of 30g

Other: Rye bread intervention

Wheat bread intervention

ACTIVE COMPARATOR

4 week wheat bread diet intervention with dietary fibre intake of 5-20g prior to two other arms

Other: Wheat bread diet

Interventions

Rye bran bread intervention OTHER

4 week dietary intervention rich in rye bran bread

Rye bran bread intervention

Rye bread intervention OTHER

4 week dietary intervention rich in rye bread

Rye bread intervention

Wheat bread diet OTHER

4 week dietary intervention rich in wheat bread as an active comparator for previous two interventions

Wheat bread intervention

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 23-30 kg/m2
• abdominally obese (waist circumference \>90 cm (men)/ \>80 cm (women))
• gastrointestinal symptoms

You may not qualify if:

• celiac diseases
• extended allergies
• exceptional diets
• IBD patients
• recent (2 mo) use of antibiotic

Sponsors & Collaborators

• University of Eastern Finland: lead
• VTT Technical Research Centre of Finland: collaborator

Related Publications (4)

• Lappi J, Mykkanen H, Bach Knudsen KE, Kirjavainen P, Katina K, Pihlajamaki J, Poutanen K, Kolehmainen M. Postprandial glucose metabolism and SCFA after consuming wholegrain rye bread and wheat bread enriched with bioprocessed rye bran in individuals with mild gastrointestinal symptoms. Nutr J. 2014 Nov 4;13:104. doi: 10.1186/1475-2891-13-104.

  PMID: 25370913 RESULT

• Lappi J, Aura AM, Katina K, Nordlund E, Kolehmainen M, Mykkanen H, Poutanen K. Comparison of postprandial phenolic acid excretions and glucose responses after ingestion of breads with bioprocessed or native rye bran. Food Funct. 2013 Jun;4(6):972-81. doi: 10.1039/c3fo60078e. Epub 2013 May 14.

  PMID: 23674066 RESULT

• Raninen K, Lappi J, Kolehmainen M, Kolehmainen M, Mykkanen H, Poutanen K, Raatikainen O. Diet-derived changes by sourdough-fermented rye bread in exhaled breath aspiration ion mobility spectrometry profiles in individuals with mild gastrointestinal symptoms. Int J Food Sci Nutr. 2017 Dec;68(8):987-996. doi: 10.1080/09637486.2017.1312296. Epub 2017 Apr 9.

  PMID: 28391735 RESULT

• Keski-Rahkonen P, Kolehmainen M, Lappi J, Micard V, Jokkala J, Rosa-Sibakov N, Pihlajamaki J, Kirjavainen PV, Mykkanen H, Poutanen K, Gunter MJ, Scalbert A, Hanhineva K. Decreased plasma serotonin and other metabolite changes in healthy adults after consumption of wholegrain rye: an untargeted metabolomics study. Am J Clin Nutr. 2019 Jun 1;109(6):1630-1639. doi: 10.1093/ajcn/nqy394.

  PMID: 31136658 DERIVED

MeSH Terms

Conditions

Intestinal Diseases; Glucose Metabolism Disorders; Inflammation

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marjukka Kolehmainen, Professor

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 8, 2018
• Study Start: January 1, 2011
• Primary Completion: December 31, 2012
• Study Completion: December 31, 2017
• Last Updated: June 20, 2018

Record last verified: 2018-06